Effectiveness of Tapentadol Prolonged Release (PR) Compared with Oxycodone/Naloxone PR for the Management of Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-Label, Phase 3b/4 Study
Effectiveness of Tapentadol Prolonged Release (PR) Compared with Oxycodone/Naloxone PR for the Management of Severe Chronic Low Back Pain with a Neuropathic Component: A Randomized, Controlled, Open-Label, Phase 3b/4 Study
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DOI：
10.1111/papr.12308
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发表时间：
2016-06-01
期刊：
影响因子：
2.6
通讯作者：
Steigerwald, Ilona
中科院分区：
文献类型：
--
作者：
Baron, Ralf;Likar, Rudolf;Steigerwald, Ilona
ObjectiveTo evaluate the effectiveness of tapentadol prolonged release (PR) vs. oxycodone/naloxone PR in non-opioid-pretreated patients with severe chronic low back pain with a neuropathic pain component.MethodsEligible patients (average pain intensity [numerical rating scale-3 (NRS-3)] 6; painDETECT positive/unclear) were randomized to twice-daily tapentadol PR 50mg or oxycodone/naloxone PR 10mg/5mg. After a 21-day titration (maximum twice-daily doses: tapentadol PR 250mg, or oxycodone/naloxone PR 40mg/20mg plus oxycodone PR 10mg), target doses were continued for 9weeks. The primary effectiveness endpoint was the change in NRS-3 from baseline to final evaluation; the exact repeated confidence interval (RCI) for tapentadol PR minus oxycodone/naloxone PR was used to establish noninferiority (upper limit
